EL-ACL SCREEN; EL-ACL IGM, IGG, IGA

K060176 · Theratest Laboratories, Inc. · MID · Feb 7, 2006 · Immunology

Device Facts

• Record ID: K060176
• Device Name: EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
• Applicant: Theratest Laboratories, Inc.
• Product Code: MID · Immunology
• Decision Date: Feb 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.

Device Story

TheraTest EL-aCL™ Screen and TheraTest EL-aCL™ IgM, IgG, IgA are in vitro diagnostic immunoassays. Device utilizes human serum samples to detect and quantify autoantibodies directed against cardiolipin. Intended for use in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in the diagnosis and management of patients with suspected autoimmune conditions associated with anti-phospholipid antibodies. Device provides quantitative or qualitative measurement of specific antibody classes (IgM, IgG, IgA) or a screening result, aiding in clinical decision-making regarding autoimmune disease status.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic immunological test system. Principle of operation involves detection of autoantibodies against cardiolipin in human serum. Class II device (Product Code: MID).

Indications for Use

Indicated for use in clinical laboratories for the in vitro detection and measurement of anti-cardiolipin autoantibodies in human serum. No specific patient population, age, or contraindications provided.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

FEB 7 2006 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Theratest Laboratories, Inc. c/o Marius Teodorescu, M.D., Ph.D. President and CEO 1111 N. Main St. Lombard, IL 60148

Re: k060176

Trade/Device Name: TheraTest EL-aCL™ Screen and TheraTest EL-aCL™ IgM, IgG, IgA Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies, immunological test system Regulatory Class: Class II Product Code: MID Dated: January 17, 2006 Received: January 23, 2006

Dear Dr. Teodorescu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter will anow you to ought anding of substantial equivalence of your device to a legally premarked notification: "The PDF maning sification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please IT you desire specific at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general information on your Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert H. Becker

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):_k060176

Device Name: TheraTest EL-aCL™ screen and TheraTest EL-aCL™ IgM, IgG, IgA

Indications For Use: "The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mana chon

Division Sign-Off

Office of In Vitro Diagnost Device Evaluation and Safety

510(k) Ko60176